[Federal Register Volume 62, Number 107 (Wednesday, June 4, 1997)]
[Notices]
[Page 30603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0189]


Recovery of Investigational New Drugs From Clinical 
Investigators; Revised Compliance Policy Guide; Availability

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of revised compliance policy guide (CPG) 7132c.05 
entitled, ``Recovery of Investigational New Drugs from Clinical 
Investigators.'' Revised CPG 7132c.05 deletes obsolete drug citations 
in the Code of Federal Regulations. These references were superseded 
under the investigational new drug rewrite (IND Rewrite). Revised CPG 
7132c.05 clarifies the terminology used to classify the recovery of 
investigational new drugs from clinical investigators consistent with 
existing regulations. In addition, consistent with the current CPG, 
this policy continues to apply to new animal drugs being studied under 
investigational new animal drug applications.

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of revised CPG 
7132c.05 ``Recovery of Investigational New Drugs from Clinical 
Investigators '' (CPG 7132c.05) to the Director, Division of Compliance 
Policy (HFC-230), Office of Enforcement, 5600 Fishers Lane, Rockville, 
MD 20857. Send one self-addressed adhesive label to assist that office 
in processing your requests. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the guidance. Submit written comments on 
revised CPG 7132c.05 to the Dockets Management Branch (HFA-305), Food 
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 
20857.

FOR FURTHER INFORMATION CONTACT: JoAnne C. Marrone, Office of 
Regulatory Affairs (HFC-230), Food and Drug Administration, 5600 
Fishers Lane, Rockville MD 20857, 301-827-1242.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA extensively revised its regulations governing the submission 
and review of IND's on March 19, 1987. These new regulations, called 
the IND Rewrite, were part of FDA's ongoing efforts to improve and 
streamline the new drug approval process. There are several provisions 
in the regulations that refer to the return of unused supplies to the 
sponsor of the IND. This revised CPG is intended to clarify the 
terminology to be used when it is necessary to recover investigational 
drugs from clinical investigators, consistent with the regulations.
    This guidance document represents the agency's current thinking on 
the recovery of investigational drugs from clinical investigators. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statute, 
regulations, or both.

II. Request for Comments

    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments on the guidance. Two 
copies of any comment are to be submitted, except that individuals may 
submit one copy. Comments and requests for copies are to be identified 
with the docket number found in brackets in the heading of this 
document. A copy of revised CPG 7132c.05 and received comments may be 
seen in the office above between 9 a.m. and 4 p.m., Monday through 
Friday.

III. Electronic Access

    An electronic version of the revised CPG (Chapter 4, Sec. 444.100) 
is also available via Internet using the World Wide Web (www) (connect 
to the ORA home page at http://www.fda.gov/ora/compliance-- 
ref/cpg).

    Dated: May 27, 1997.
Ronald G. Chesemore,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 97-14471 Filed 6-3-97; 8:45 am]
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